Stem Cell Theranostics' clinical trial in a dish

Imagine the day when drug discovery takes months rather than decades. When nonregenerating tissues like the heart, brain and ear can repair themselves after trauma.

It’s not as futuristic as it may sound.

Andrew Lee and Divya Nag, co-founders of Palo Alto-based Stem Cell Theranostics, are advancing on those goals. In particular, they’re focusing on heart disease, the leading cause of death worldwide.

Stem Cell Theranostics is developing technology that lets doctors take a skin cell, turn it into a heart cell and then use these cells for treatment of heart disease.

Lee said the regenerative therapy will take time to develop. But the process of converting cells can already be used to help screen new drugs.

If Lee and Nag succeed, they could turn the $80 billion drug-discovery market on its head, reduce the risks of drug testing during clinical trials and speed up Food and Drug Administration approval on new drugs.

Stem Cell Theranostics is one of the first med-tech companies to come through the Stanford University’s nonprofit StartX Med program, which incubates health startups.

Much of Stem Cell Theranostics’ work is based on the research of Shinya Yamanaka, who was looking for alternatives to the controversial use of embryonic stems cells. He tried to find the core four genes that allow embryonic cells to turn into any other cell in the human body.

He discovered those genes and invented what is called Induced Pluripotent Stem Cells, or IPSCs.

“He took those four genes and put them in a skin cell and turned the skin cell into a pluripotent cell,” Lee said.

It’s those cells that Lee and Nag can use for drug testing on heart cells.

Lee has been working on the therapy for seven years.

“We call it a clinical trial in a dish,” he said.

Instead of spending five to six years testing drugs on mice, rats and hamsters, which don’t respond the same way as people, there is an alternative that can prove more reliable in clinical trials on humans, Lee said.

Still, it takes 12 years and $1.8 billion to bring a drug to market so the company will partner with several major pharmaceuticals for drug development, Lee said. He declined to identify those partners.

Dr. Thomas Fogarty, a founder of the Fogarty Institute of Medicine, said the invention of the pluripotent cell moves stem cell research away from the ethnical debate. But the ability to bring it to market could be 15 years out, he said.

The researchers may succeed in accomplishing their goals but there are many hurdles to overcome even before FDA approval. All of which is unpredictable, and key factors in the success of medical innovation in the U.S.

“We have a ways to go, but there are things we can do with technology now we couldn’t do five years ago,” he said.